International safety notice

Parameters Combined in the Same Product - Class II

Brazil / Anvisa · BRA · Aug 8, 2017

Key facts

Title Parameters Combined in the Same Product - Class II
Regulator Brazil / Anvisa
Country BRA
Brand Trade name: Quimicosi E II Vitros Product Efficiency Checker* Technical name: Combined Parameters In The Same Product - Class II ANVISA registration number: 10132590232 Risk class: II Affected model: 12 x 3 ml of level I lyophilized checker; Affected serial numbers: SKU: 8231474 |
Manufacturer EMPRESA DETENTORA DO REGISTRO JOHNSON JOHNSON DO BRASIL IND E COM DE PROD PARA SAÚDE LTDA CNPJ 54516661000101 LOCALIZADA NA AV JUSCELINO KUBITSCHEK Nº 2041 ANDARES 8º E 9º COMPLEXO JK BLOCO B SÃO PAULO SP FABRICANTE ORTHOCLINICAL DIAGNOSTICS 100 INDIGO CREEK DRIVE ROCHESTER NY 146265101 ESTADOS UNIDOS TELEFONE 55 12 39327977 EMAIL GBUOSIITSJNJCOM
Models 10132590232, K4852, 8231474
Date Aug 8, 2017
Regulator page anvisa.gov.br

At a glance

  • No Recall
  • No Field safety notice
  • 1–9 Matching device models in FDA data
  • 1–9 Matching catalog numbers in FDA data

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About International device safety notices

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Source: National medical device regulators (as listed), compiled by Orca1

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